Implantable prosthesis having a self-sealing valve

ABSTRACT

An implantable breast prosthesis including a flexible container formed from a medical grade of silicone elastomer, a self-sealing valve provided on the inside surface of the container, the valve being formed of a self-sealing gel and including sufficient barium sulfate, bismuth subcarbonate or tantalum powder so that the valve is radiopaque for easy location after implanting in the body, and an injection assembly for inflating the container with a fluid after implantation in the body, said assembly including a catheter for penetrating the valve and a syringe for injecting into or removing fluid from the container through the catheter, the fluid comprising either a saline solution or a gel. The selfsealing gel can also be used as a valve for a catheter or in a fistula for hemodialysis.

[22] Filed:

Sanders et a1.

[ Nov. 18, 1975 IMPLANTABLE PROSTHESIS HAVING A SELF-SEALING VALVE [75] Inventors: David H. Sanders, Deerfield, 111.;

Henry W. Lynch; Sennen Uy, both of Racine, Wis.

[73] Assignee: Medical Engineering Corporation,

Racine, Wis.

June 7, 1974 [21] Appl. No.: 477,307

[52] US. Cl.....1 3/36; 128/214 R; 128/349 BV; 3/1 [51] Int. Cl. A61F 1/24; A41C 3/10 [58] Field of 3/1, 36; 128/349 B, 349 BV, 128/214 R, 2 R, DIG. 25

[56] References Cited 3,752,162 8/1973 Newash 3/1 X Primary Examiner-Ronald L. Frinks Attorney, Agent, or FirmRonald E. Barry [57] ABSTRACT An implantable breast prosthesis including a flexible container formed from a medical grade of silicone elastomer, a self-sealing valve provided on the inside surface of the container, the valve being formed of a self-sealing gel and including sufficient barium sulfate, bismuth subcarbonate or tantalum powder so that the valve is radiopaque for easy location after implanting in the body, and an injection assembly for inflating the container with a fluid after implantation in the body, said assembly including a catheter for penetrating the valve and a syringe for injecting into or removing fluid from the container through the catheter, the fluid comprising either a saline solution or a gel. The selfsealing gel can also be used as a valve for a catheter or in a fistula for hemodialysis.

4 Claims, 7 Drawing Figures US. Patent Nov. 18, 1975 Sheet 1 of2 3,919,724

US. Patsnt Nov. 18, 1975 Sheet 2 of2 3,919,724-

BACKGROUND OF THE INVENTION Implantable breast prostheses of the type disclosed in US. Pat. No. 3,293,663, issued Dec. 27, 1966 to Thomas D. Cronin entitled Surgically Implantable Human Breast Prosthesis and US. Pat. No. 3,665,520, issued May 30, 1972 to Colette Perras et al. for Breast Prosthesis, include flexible containers prefilled with a silicone gel. These prostheses are then inserted into the body through an opening which must be of sufficient size to accommodate the prefilled prosthesis. The more recent type of prosthesis does not include any tissue fixation material on the outer surface and after implantation in the body is free to move within the fibrous capsule that forms around the implant. This presents problems in an inflated type implant because of the difficulty in trying to locate the inflation plug or valve.

SUMMARY OF THE INVENTION The breast prosthesis of the present invention is designed to be filled after being implanted in the body. By inflating the prosthesis after insertion into the body a smaller incision is required. The prosthesis is provided with a valve or plug formed of a self-sealing gel which can be radiopaque. The prosthesis is filled by injecting a fluid, either saline solution or gel, through a catheter which has been inserted through the self-sealing plug. After filling the prosthesis, the incision is closed and allowed to heal. After the incision has healed and the fibrous capsule has formed around the implant, it may become necessary to either increase or decrease the amount of fluid within the container. By providing a radiopaque valve on the implant, the valve can be quickly and easily located. The fluid within the container can be increased or decreased without making any incision in the body.

The self-sealing valve can also be used in catheters for injecting a gaseous medium into the secondary lumen for a cuff. In a further application, the self-sealing plug or valve can be embedded in the wall of a fistula used for hemodialysis work.

Other objects and advantages of the present invention will become more readily apparent from the following description when read in conjunction with the drawings, in which:

FIG. 1 is a top view of the breast prosthesis of this invention showing the location of the radiopaque selfsealing valve;

FIG. 2 is a view of the breast prosthesis in the uninflated and rolled up condition ready for insertion into the body;

FIG. 3 is a view of the portion of the breast prosthesis which protrudes from the body after being partially inserted showing the penetration of the valve by a catheter and needle;

FIG. 4 is a view similar to FIG. 3 showing the catheter with the needle removed and a syringe connected to the catheter for inflating the implant;

FIG. 5 is a partial view in section of the prosthesis showing the self-sealing valve;

FIG. 6 is a cross sectional view of a catheter showing the self-sealing plug in the lumen for the cuff; and

FIG. 7 is a schematic view of a fistula for hemodialysis showing the seIf-sealing plug embedded in the wall of the fistula.

DESCRIPTION OF THE INVENTION Referring to the drawing, the breast prosthesis 10 of this invention as shown in FIG. 1 includes a flexible container 12 and a self-sealing valve or plug 14. The container 12 is formed from a medical grade of silicone elastomer such as MEC 127 although an organo siloxane copolymer of the type as set forth in US. Pat. No. 3,665,520 can also be used. The containermaterial should have low modulus, but high ultimate tensile and tear strengths.

In accordance with the invention, the valve or plug 14 is located on the inside wall of the container 12 and preferably on the lower end of the container or on the center of the front of the container. As seen in FIG. 1, the valve 14 is located at the lower end of the container 12. A prosthesis having the valve 14 located in this position would normally be inserted into the breast through a small incision made at the perimeter of the breast. If the prosthesis is implanted through the periareola of the breast, the valve 14 should be located in the center of the prosthesis.

The valve 14 includes a shell 16 made of the same material as used for making the container 12. The shell 16 is filled with a silicone gel 18 of the type set forth in US. patent application Ser. No. 428,396, filed on Dec. 26, 1973 and entitled Variable Volume Prosthetic Assembly. The gel has a slightly higher penetrometer reading so that it will be self-sealing on penetration by a needle. The valve 14 is bonded to the inside wall of the container.

Means can be provided for locating the valve after implanting in the body. Such means is in the form of a radiopaque material which is added to the gel. In the preferred embodiment, barium sulfate is added to the gel prior to filling the shell 16. The addition of up to 5% by weight of barium sulfate, bismuth subcarbonate or powdered tantalum, to the gel is sufficient for this purpose.

In use, the breast prosthesis 10 is rolled up as shown in FIG. 2, with the self-sealing valve 14 located at one end of the implant 10. The valve 14 should be at approximately a right angle to the axis of the rolled up container 12. The prosthesis 10 is left in the rolled up form for implantation.

The prosthesis 10in the rolled up condition is partially inserted under-the breast leaving the valve 14 protruding or exposed, as seen in FIG. 3. A catheter 20 having a needle 22 extending through the center of the catheter is used to pierce the valve 14. The valve 14 should be pulled slightly away from the body to elongate the container and assure that a cavity 24 is formed within the container behind the valve 14. The valve 14 is penetrated by the needle 22 to allow the catheter 20 to penetrate the valve 14. By pushing the valve 14 away from the body, the tip of the needle 22 will not pierce the wall of the container 12.

The prosthesis 10 is filled by removing the needle 22 from the catheter 20 and connecting an extension tube 26 for a syringe 30 to the catheter. The valve 14 for the prosthesis 10 is then pushed completely into the body. After the valve 14 has been inserted completely into the body, the prosthesis is filled with a saline solution or a silicone gel to the desired volume. The flow of the solution into the prosthesis can be controlled by a hand valve 28 provided in the extension tube 26.

After implantation the prosthesis may roll within the cavity in the body. If it is desired to either enlarge or 3 deflate the prosthesis, the valve can be located by X- ray. After the valve has been located the saline solution or gel can be either added to or withdrawn from the implant in the same manner as originally filled except that an incision is not required in this procedure.

In FIG. 6, the self-sealing valve 14 is shown bonded in the entrance to the secondary lumen 32 for a catheter 34. In this regard, the catheter 34 includes a main lumen 36 and a cuff 38 connected to the secondary lumen 32 through a port 40. Gas is forced into the secondary lumen 32 to inflate the cuff 38.

In accordance with this form of the invention, the self-sealing plug or valve 14 is bonded in the open end 35 of the lumen 32. Air is injected into the lumen by inserting a needle through the plug 14. After the cuff 38 has been inflated, the needle is withdrawn and the cuff remains inflated.

In the embodiment of the invention shown in FIG. 7, the self-sealing plug 14 is used to provide for the connection of a dialysis machine to a fistula 42. The fistula 42 is in the form of a hollow tube 50 which is connected through the skin 44 to an artery and a vein 48. The fistula forms a shunt for bypassing blood to the dialysis machine.

The plug 14 is embedded in the wall of the tube 50. The dialysis machine is connected to the tube by inserting a catheter 52 into the tube 50 through the plug 14. The catheter is withdrawn after dialysis has been completed and the tube 50 is automatically sealed.

We claim:

1. An implantable prosthesis comprising a flexible container having the shape of a breast, a self-sealing valve provided on the inside surface of said container,

a shell formed from a flexible medical grade material, a self-sealing gel completely filling said shell, a radiopaque material being combined with said gel, a fluid in said container, and means for injecting and withdrawing said fluid through said valve into or out of said container said radiopaque material being selected from the group consisting of barium sulfate, bismuth subcarbonate and tantalum.

2. The prosthesis according to claim 1 wherein said fluid is a saline solution.

3. An implantable breast prosthesis comprising a flexible container having the shape of a human breast, a self-sealing valve provided on the edge of the inside surface of the container, said valve including a shell of organosiloxane copolymer material, a self-sealing gel completely filling said shell and a radiopaque material wherein said valve can be located by X-ray after implantation, and a saline solution completely filling said container.

4. A self-sealing valve for admitting gaseous and fluid mediums into an implantable breast prosthesis after implantation of the prosthesis in the human body, said valve including a shell formed from a flexible medical grade material, a self-sealing gel filling said shell and a radiopaque material combined with said self-sealing gel. 

1. An implantable prosthesis comprising a flexible container having the shape of a breast, a self-sealing valve provided on the inside surface of said container, a shell formed from a flexible medical grade material, a self-sealing gel completely filling said shell, a radiopaque material being combined with said gel, a fluid in said container, and means for injecting and withdrawing said fluid through said valve into or out of said container said radiopaque material being selected from the group consisting of barium sulfate, bismuth subcarbonate and tantalum.
 2. The prosthesis according to claim 1 wherein said fluid is a saline solution.
 3. AN IMPLANTABLE BREAST PROSHESIS COMPRISING A FLEXIBLE CONTAINER HAVING THE SHAPE OF A HUMAN BREAST, A SELF-SEALING VALVE PROVIDED ON THE EDGE OF THE INSIDE SURFACE OF THE CONTAINER, SAID VALVE INCLUDING A SHELL OF ORGANOSILOXANE COPOLYMER MATERIAL, A SELF-SEALING GEL COMPLETELY FILING SAID SHELL AND
 4. A self-sealing valve for admitting gaseous and fluid mediums into an implantable breast prosthesis after implantation of the prosthesis in the human body, said valve including a shell formed from a flexible medical grade material, a self-sealing gel filling said shell and a radiopaque material combined with said self-sealing gel. 